Retractor

ABSTRACT

A retractor ( 101 ) for retracting the margins of a wound opening ( 103 ) comprises an inner anchoring O-ring ( 105 ) attached to a cylindrical sleeve ( 106 ) at a distal end and a reinforcing O-ring ( 109 ) attached to a proximal end of the sleeve ( 106 ). The sleeve ( 106 ) is led between an inner ring part ( 110 ) and a corresponding recess ( 116 ) in an outer ring part ( 111 ). The outer ring part ( 111 ) has anchor formations ( 120 ) over which the proximal end of the sleeve ( 106 ) is attached to anchor the sleeve ( 106 ). To retract the wound opening ( 103 ) the sleeve ( 106 ) is pulled while the guide rings ( 110, 111 ) are moved against the tissue surrounding the wound opening ( 103 ). This pulls the inner O-ring ( 105 ) against the inside of the tissue adjacent the wound opening ( 103 ), and retracts the wound opening ( 103 ). The sleeve ( 106 ) is manipulated locally for maximum retraction efficiency.

This application is a Continuation of Application Ser. No. 13/205,517,filed Aug. 8, 2011, now U.S. Pat. No. 8,986,202, which is a Continuationof Application Ser. No. 11/841,777, filed Aug. 20, 2007, now U.S. Pat.No. 8,012,088, which is a Continuation of Application Ser. No.10/374,523, filed Feb. 27, 2003, Now U.S. Patent No. 7,445,597, which isa Continuation of Application Ser. No. 09/849,341, filed May 7, 2001,now U.S. Pat. No. 6,582,364, which is a Continuation of Application Ser.No. 09/688,138, filed Oct. 16, 2000, now U.S. Pat. No. 6,254,534, all ofwhich are incorporated herein by reference in their entireties.

INTRODUCTION

The invention relates to a retractor. In particular the inventionrelates to a retractor for retracting the margins of an incision or anatural bodily orifice to provide maximum exposure of an organ or bodystructures for examination and/or access for surgical procedures, whilealso providing protection for the exposed sides of the incised tissue.

Various retractors are known. However in general known retractors aredifficult and cumbersome to use, and/or are relatively expensive. Inaddition known retractors are limited to use with a particular size ofincision and a particular patient anatomy.

This invention is directed towards providing an improved wound retractorwhich will overcome at least some of these problems, and in additionprovide a means of wound protection during a surgical procedure.

STATEMENTS OF INVENTION

According to the invention there is provided a surgical wound retractorcomprising:

-   -   a distal anchoring member for insertion into a wound opening;    -   a connecting means having an inner wound engaging portion and an        outer portion, the wound engaging portion being mounted to the        distal anchoring member, the connecting means having an        insertion configuration in which the inner wound engaging        portion has a reduced radial dimension and a retracting        configuration;    -   an external guide means for the outer portion of the connecting        means;    -   the external guide means being movable relative to the        connecting means to shorten the axial extent of the connecting        means and thereby bias the wound engaging portion of the        connecting member into the retracting configuration to retract        the wound opening laterally; and    -   external anchoring means for anchoring the connecting means to        maintain retraction of the opening.

In one preferred embodiment of the invention at least the inner woundengaging portion of the connecting means comprises a sleeve forextending around the wound opening to protect the opening.

In one embodiment the outer portion of the connecting means comprises asleeve extension of the inner wound engaging portion of the connectingmeans.

Preferably the connecting means comprises a generally cylindricalsleeve.

In a preferred embodiment the guide means comprises an annular ringmeans. The annular ring means preferably comprises inner and outer ringparts between which the connecting means is led. In a preferredembodiment the outer ring part includes the anchor means for anchoringthe connecting means. In one arrangement the anchor means comprisesanchor formations on the outer ring to which the connecting means isattached on retraction of the opening.

Preferably the inner ring means defines a projection for location in acomplementary recess of the outer ring with the connecting means locatedtherebetween.

In one embodiment the inner ring is a relatively loose fit in the recessof the outer ring part.

Preferably at least portion of one of the ring parts is movable from arest position in which the connecting member is substantially clampedbetween the ring parts to a release position in which at least portionof the connecting member is movable relative to the ring parts. Ideallyonly portion of the connecting member is movable relative to the ringparts in the release position.

In another embodiment the inner ring is a relatively tight fit in theouter ring part to grip the connecting member therebetween.

In one aspect of the invention the outer ring part comprises a pluralityof interconnected segments which are independently movable to facilitatelocalised release of the connecting member for adjusting of theretraction force applied at the opening. The ring part or segmentthereof is preferably manually manipulable between the clamped restposition and the release position.

In one embodiment of the invention the connecting means includes aproximal reinforcing means for engagement with the external anchoringmeans. Ideally the proximal reinforcing means is a proximal ring.

Preferably the distal anchoring means is of resilient material.Typically the distal anchoring means is an O-ring.

Preferably at least an outer surface of the guide means which engageswith the connecting means is of a material with a low coefficient offriction such as polytetrafluroethylene.

In a particularly preferred embodiment the retractor includes a platformfor attachment of another device to the retractor.

In an especially preferred arrangement one of the ring parts defines aplatform for attachment of another device to the retractor.

In another aspect the invention provides a method for retracting a woundopening using a surgical wound retractor comprising a distal anchoringmember, a connecting means having a wound engaging portion mounted tothe distal anchoring member and an outer portion, an external guidemeans for the outer portion of the connecting means and an externalanchoring means; the method comprising the steps:

-   -   positioning the distal anchoring member to be retained inside a        wound opening with the connecting means extending: outwardly        therefrom through the opening;    -   moving the external guide means relative to the outer portion of        the connecting means to shorten the axial extent of the        connecting means and thereby bias the wound engaging portion        into a retracting configuration to retract the wound opening;        and    -   anchoring the connecting means to maintain retraction of the        wound opening.

Preferably the method includes the steps of moving the external guidemeans relative to the outer portion of the connecting means to partiallyretract the wound opening, gripping the outer portion of the connectingmeans and pulling it relative to the guide means to fully retract thewound opening.

In one embodiment the method includes the steps of:

-   -   (a) gripping a local section of the outer portion of the        connecting means while the remaining section of the outer        portion of the connecting means is anchored,    -   (b) pulling the local section to increase the retraction at a        local area of the wound opening, and    -   (c) anchoring the local section of the connecting means.

Ideally the method includes repeating steps (a) to (c) for other localsections of the outer portion of the connecting means.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be more clearly understood from the followingdescription thereof given by way of example only with reference to theaccompanying drawings, in which:

FIG. 1 is an exploded view of a wound retractor according to theinvention;

FIG. 2 is a perspective view of the retractor of FIG. 1 assembled;

FIG. 3 is a side cross sectional view of the assembled retractor of FIG.2;

FIG. 4 is a perspective view of an unretracted wound opening;

FIG. 5 is a perspective view illustrating insertion of part of theretractor of FIG. 2 into the wound opening;

FIG. 6 is a side cross sectional view of the retractor of FIG. 2 afterinsertion;

FIG. 7 is a plan view of the retractor of FIG. 2 after insertion;

FIGS. 8( a) and 8(b) are side cross sectional views illustrating lateralretraction of the wound opening using the retractor of FIG. 2;

FIG. 9 is a side cross sectional view of the retractor of FIG. 2 afterlateral retraction of the wound opening;

FIG. 10 is a plan view of the retractor of FIG. 2 after lateralretraction of the wound opening;

FIG. 11 is a plan view of a part of a guide means of the retractor ofFIG. 2;

FIG. 12 is a side view of the part of FIG. 11;

FIG. 13 is a cross sectional view along the line A-A in FIG. 11;

FIG. 14 is a cross sectional view of part of another wound retractoraccording to the invention;

FIG. 15 is a cross sectional view of the retractor of FIG. 14, in use;

FIG. 16 is an exploded view of parts of another wound retractoraccording to the invention;

FIG. 17 is a perspective view of the wound retractor of FIG. 16assembled;

FIGS. 18 and 19 are perspective cut-away views of the retractor of FIG.17 in different positions;

FIG. 20 is a schematic plan view illustrating manipulation of a part ofthe retractor of FIGS. 17 to. 19;

FIG. 21 is a side cross sectional view of the retractor part in theconfiguration of FIG. 20;

FIG. 22 is a schematic plan view of the retractor part in a releaseposition;

FIG. 23 is a side cross sectional view of the retractor part in theconfiguration of FIG. 22;

FIG. 24 is a perspective view of a hand access device for use with awound retractor according to the invention;

FIG. 25 is a side cross sectional view of the retractor of FIG. 2 withthe hand access device of FIG. 24 in position;

FIG. 26 is a perspective view of a drape for use with a wound retractoraccording to the invention;

FIG. 27 is a side cross sectional view of the retractor of FIG. 2 withthe drape of FIG. 26 in position;

FIG. 28( a) is a perspective view of a form retaining device in apliable state for use with a wound retractor according to the invention;

FIG. 28( b) is a perspective view of the form retaining device of FIG.28( a) in a stiff state;

FIG. 29 is a side cross sectional view of the retractor of FIG. 2 withthe stiffened form retaining device of FIG. 28( b) in position;

FIG. 30 is an exploded view of the form retaining device of FIG. 28 anda clamp;

FIG. 31 is a side view of the form retaining device of FIG. 28 and theclamp of FIG. 31; and

FIG. 32 is a side cross sectional view of the retractor of FIG. 2 withthe form retaining device of FIG. 28 and the clamp of FIG. 30 inposition.

DETAILED DESCRIPTION

Referring to FIGS. 1 to 13 there is illustrated a wound retractor 101according to the invention, which in the case illustrated is used toretract the margins of a wound such as an abdominal wound opening 103,as illustrated in FIG. 4.

The reactor 101 comprises a distal anchoring member, in this case in theform of a resilient inner O-ring 105, for insertion into the woundopening 103, and a connecting means, in this case in the form of anelastomeric sleeve 106 which is substantially cylindrical. The sleeve106 has an inner wound engaging portion and an outer portion, and thewound engaging portion is attached to the inner O-ring 105. The sleevehas an insertion configuration in which the inner wound engaging portionhas a reduced radial dimension and a retracting configuration to retractthe wound opening 103 laterally.

An external guide means is provided for the outer portion of the sleeve106, and in this case the guide means comprises an inner ring part 110and an outer ring part 111 between which the sleeve 106 is led. Theretractor 101 includes external anchoring means for anchoring the sleeve106 to maintain retraction of the wound opening 103, and in this casethe anchoring means is provided by a plurality of anchor formations 120on the outer surface of the outer ring part 111 (FIG. 2), the formations120 extending radially outwardly to define hooks.

The outer ring part 111 is of the same annular shape as the inner ringpart 110 but has a larger diameter and a recess 116. The inner ring part110 is of a relatively stiff material and mates with the outer ring part111 in the recess 116 to slidably retain the sleeve 106 therebetween, asillustrated in FIG. 3. In this case the ring parts 110, 111 are arelatively loose fit to facilitate movement of the ring parts 110, 111relative to the sleeve 106 to shorten the axial extent of the sleeve 106and thereby bias the wound engaging portion into the retractingconfiguration to retract the wound opening 103 laterally.

The ring parts 110, 111 are of a material with a low coefficient offriction such as Polytetrafluoroethylene (PTFE). PTFE is a tough,non-resilient material of moderate tensile strength and with excellentlubricity.

The retractor 101 also includes a proximal reinforcing means forengagement with the anchor formations 120, and in this case thereinforcing means is provided by a resilient outer O-ring 109 of amaterial which is flexible relative to the inner O-ring 105. The outerO-ring 109 is attached to the proximal end of the sleeve 106, the rings105, 109 helping to maintain the open shape of the sleeve 106 at itsextremities (FIG. 2).

In use the inner O-ring 105 and the sleeve 106 are squeezed into theinsertion configuration for insertion of the inner O-ring 105 into thewound opening 103 (FIG. 5). The inner O-ring 105 is of a polymericmaterial which facilitates scrunching up of the inner O-ring 105 into alow-profile, elongate shape, as illustrated in FIG. 5, to facilitatecase of use. On release of the inner O-ring 105, the resilient O-ring105 returns to its normal 0-shape overlapping an inner edge of the woundopening 103 to safely anchor the retractor 101 in the wound, asillustrated in FIG. 6. As may be seen from FIGS. 6 and 7, afterinsertion of the inner O-ring 105, the wound opening 103 issubstantially closed and the sleeve 106 is in a wrinkled compressedconfiguration.

The sleeve 106 is then pulled while pushing the ring parts 110, 111against the tissue surrounding the wound opening 103, as illustrated inFIG. 8( a), to shorten the axial extent of the sleeve 106 and therebybias the wound engaging portion into the retracting configuration toretract laterally the right-hand side (as viewed in FIG. 8( a)) of thewound opening 103. The right-hand side of the outer O-ring 109 is hookedaround the formations 120 to maintain the right-hand side of the woundopening 103 retracted (FIG. 8( b)). The left-hand side of the sleeve 106is then pulled while pushing the ring parts 110, 111 to retractlaterally the left-hand side of the wound opening 103, as illustrated inFIG. 8( b). The left-hand side of the outer O-ring 109 is then hookedaround the formations 120 to maintain the entire wound opening 103 fullyretracted, as illustrated in FIGS. 9 and 10.

The separate formations 120 and the configuration of the wound retractor101 generally allow the sleeve 106 to be readily manipulated locally asillustrated in FIGS. 8( a) and 8(b) to provide an optimised retraction,force. Thus, the manipulation is not simply limited to a single verticalaxis but can be carried out in several different directions by pullingof the sleeve 106, and localised hooking of the outer O-ring 109 to theappropriate formation 120. In this way the retractor can be tailored toa particular application.

The recess 116 against which the sleeve 106 is slidably retained by theinner ring part 110 is C-shaped with an extended upper lip 117, as maybe seen in FIG. 13. The upper lip 117 maintains the inner ring part 110safely within the recess 116 regardless of the pulling direction ortensile pulling force exerted on the sleeve 106. It is preferable topull the sleeve 106 in a non-vertical direction and to perform localisedhooking of the outer O-ring 109, and the extended upper lip 117encourages non-vertical pulling of the sleeve 106.

The elastomeric sleeve 106 lines the side of the retracted wound opening103, as illustrated in FIG. 9, and thus acts both as a means of woundretraction and wound protection.

The surgical wound retractor is of simple construction, is easy to useand can be manufactured inexpensively to provide a disposable unit.

A single wound retractor according to the invention may be used for awide range of incision sizes and to achieve a range of differentlocalised retraction forces which are required to accommodate theincision, the patient anatomy and the surgical procedure to beperformed. In the retractor of FIGS. 1 to 10 the sleeve 106 is arelatively tight fit between the outer and inner guide ring parts110,111. It is also possible to configure the outer and inner ring parts110, 111 so that the inner ring part 110 is a relatively looser fit inthe outer part 111. In this case the guide means comprises an outer ringpart or other annular shape within which slides a second component. Thesecond component is of the same annular shape as the outer ring part butwith a lesser diameter and has an exterior compartmental recess designedso that the outer ring pan fits loosely around the second component andboth can easily slide relative to each other. The components fit looselytogether so that an elastomeric sleeve can fit in the gap between themand slide therein. Such an arrangement is illustrated in FIGS. 14 and15. On pulling of a local area of the sleeve i06 as indicated in FIG. 15the inner ring part 110 moves to an appropriate side clamping the sleeve106 at that opposite side while allowing local manipulation of thegripped section of sleeve allowing the local retraction force at thegripped side to be optimised prior to anchoring of the sleeve at thatside. This procedure may be repeated at other local regions of thesleeve 106.

Referring to FIGS. 16 to 23 there is illustrated another wound retractor150 according to the invention which is similar to the wound retractor101 described with reference to FIGS. 1 to 13 and like parts areassigned the same reference numerals in FIGS. 16 to 23.

In this case the guide means comprises the inner ring part 110 and anouter PTFE ring part 151 configured so that the outer ring part 151engages the inner ring part 110 at a plurality of discrete pointscircumferentially spaced around the outer ring part 151 to clamp thesleeve 106 between the inner and outer ring parts 110, 151 at eachdiscrete point. The outer ring part 151 comprises a plurality ofinterconnected segments 155 circumferentially spaced around the outerring part 151 which press on the inner ring part 110 to clamp the sleeve106 and are independently movable to facilitate localised release of thesleeve 106 for adjustment of the retraction force. Cut-out T-slots 156are provided between the segments 155 and a main body 158 of the outerring part 151, and handles 160 project radially outwardly of the mainbody 158 of the outer ring part 151 intermediate the segments 155.

In use, adjacent handles 160 are manually gripped as illustrated in FIG.20 to apply a release force in the direction of arrows A which in turnpulls the local segment 155 in the direction of arrow B from a restposition damping the sleeve 106 (FIGS. 20 and 21) to a release position(FIGS. 22 and 23) in which the sleeve 106 is readily pulled andmanipulated locally. By releasing the clamp between the inner ring part110 and the segment 155 the elastomeric sleeve 106 in readily slid fromone position to another. This arrangement is particularly advantageousto facilitate local manipulation of the retraction force.

In general, the wound retractor 150 according to the invention isemployed by inserting the inner O-ring 105 into a wound opening 103 andpulling the sleeve 106 so that the inner O-ring 105 lies flat againstthe interior anatomical surface. The inner O-ring 105 anchors theretractor 150 in the wound and prevents the elastomeric sleeve 106 fromslipping out of the wound opening 103. The guide means clamp is thenreleased by squeezing handles 160 and the ring parts 110, 151 are sliddown the elastomeric sleeve 106 until they come into contact with theexterior anatomical surface. Retraction is achieved by pulling thesleeve 106 to shorten the distance between the inner O-ring 105 and thering parts 110, 151 and thereby displace the elastomeric sleeve 106laterally and with it the margins of the wound opening 103. Theelastomeric sleeve 106 is anchored to maintain retraction of the woundopening 103 by releasing the handles 160 of the outer ring part 151 toclamp the sleeve 106.

The wound retractors according to the invention also provides a platformon which a wide range of devices may be mounted. In one case theplatform is provided by an inner projection part of the inner ring part110 on which a ring part 171 with a complementary recess 172 may beeasily fitted somewhat in the manner of a snap-type engagement. Variousdevices may be provided with such a ring part 171. For example, asillustrated in FIGS. 24 and 25 the device may be a hand access device175 for use in laparoscopic surgery. Alternatively the device may be adrape 180 (FIGS. 26 and 27) or a form retaining device 185 which ismanipulated to the form of, for example, an organ 187 to be held backand from which air is then evacuated along an evacuation line 186 toretain the desired organ holding configuration (FIGS. 28 and 29).

The platform may alternatively be provided by a clamp 200 as illustratedin FIGS. 30 to 32. The clamp 200 comprises an upper jaw 201, a lower jaw202, a clip 203 and an arm 204.

The clamp 200 is assembled by screwing the clip 203 to the base of thelower jaw 202, sliding the upper jaw 201 over the lower jaw 202 toengage the male projecting parts 208 within the corresponding femalerecesses 209 and extending the arm 204 through the open mouth 207between the upper and lower jaws 201, 202. A plurality of teeth 205 areprovided on the arm 204, the teeth 205 being sized to project upwardlythrough a recess 206 in the upper jaw 201 when the arm 204 is within theopen mouth 207. The teeth 205, as shown more clearly in FIG. 31, areshaped such that the arm 204 may be pulled back through the open mouth207 in a ratchet-type arrangement but cannot be pushed forward again. Asuitable material for the clamp components 201, 202, 203, 204 is springsteel.

Various devices may be attached to the free end of the arm 204, such asthe form retaining device 185, as illustrated in FIG. 30. In use theclip 203 is securely fixed to the wound retractor 101 by a snap-fitarrangement with the form retaining device 185 extending into the woundopening 103, as illustrated in FIG. 31. The form retaining device 185 isthen ratcheted laterally across the wound opening 103 to retract, forexample, an internal organ 220. The ratchet configuration of the clamp200 and the rigidity of the form retaining device 185 ensure that theinternal organ 220 is securely maintained in a desired position.

It will be appreciated that any of the embodiments of the woundretractor according to the invention may be used as a platform on whichto mount other devices for use in various surgical procedures. Suchdevices may include: a capping device to cover the incision site ororifice; a hand-access device to allow the surgical procedure to beconverted from an open procedure into a hand-assisted laparoscopicprocedure; an instrument port for the insertion of instruments; a trocarfor use in laparoscopic surgery; an internal organ retractor to assistin the displacement of internal structures from the operative field; oran illuminating means to deliver illumination to an area shaded from thetheatre lights. It will be clear to those skilled in the art that theenhancements are not limited to the brief list mentioned here.

The wound retractor may be constructed in other annular shapes. Forexample the distal and proximal rings attached to the elastomeric sleevemay be oval or elliptical instead of circular.

The retractor may be used to retract and protect the margins of anatural bodily orifice such as the anus or vagina, or can be used toretract and protect the edges of a man-made stoma such as is created fortracheostomy or following gastrointestinal surgery.

The invention is not limited to the embodiments hereinbefore describedwhich may be varied in both construction and detail.

The invention claimed is:
 1. A medical device, comprising: a woundprotector, including: a proximal ring, a distal ring, and a sleeveextending between the proximal ring and the distal ring, wherein thedistal ring and a distal portion of the sleeve are configured forinsertion into an incision, and the proximal ring and a proximal portionof the sleeve are configured for positioning outside of the incision;and a proximal assembly coupled to the proximal ring, the proximalassembly including: an outer member coupled to the proximal ring, aninner member, wherein at least part of the inner member is received bythe outer member, and the inner member slidably engages the outermember, and an access portion providing a passageway through theproximal assembly.
 2. The medical device of claim 1, wherein the outermember has an inner circumferential portion, the inner member has anouter circumferential portion, and the inner circumferential portionslidably engages the outer circumferential portion.
 3. The medicaldevice of claim 1, wherein one of the inner member and the outer memberincludes a recess, and the other of the inner member and the outermember includes a portion that protrudes into the recess.
 4. The medicaldevice of claim 1, wherein the outer member is annular.
 5. The medicaldevice of claim 1, wherein the inner member is annular.
 6. The medicaldevice of claim 1, wherein the access portion includes a cylindricalport.
 7. The medical device of claim 1, wherein the access portionextends proximally from a proximal surface of the inner member.
 8. Themedical device of claim 7, wherein a proximal end of the access portionincludes a proximal opening.
 9. The medical device of claim 8, whereinthe access portion extends distally from a distal surface of the innermember.
 10. The medical device of claim 9, wherein a distal end of theaccess portion includes a distal opening.
 11. The medical device ofclaim 1, wherein a longitudinal axis of the access portion is coaxialwith a longitudinal axis of the wound protector.
 12. A medical device,comprising: a wound protector, including: a proximal ring, a distalring, and a sleeve extending between the proximal ring and the distalring, wherein the distal ring and a distal portion of the sleeve areconfigured for insertion into an incision, and the proximal ring and aproximal portion of the sleeve are configured for positioning outside ofthe incision; and a proximal assembly coupled to the proximal ring, theproximal assembly including: a base coupled to the proximal ring, thebase having a proximal surface and a distal surface, and an accessportion configured to provide passage through the base, wherein theaccess portion extends proximally from the proximal surface of the base,the access portion has a proximal end with a proximal aperture, and theproximal aperture is spaced in a proximal direction from the proximalsurface of the base.
 13. The medical device of claim 12, wherein theaccess portion has a central passageway in fluid communication with theproximal aperture.
 14. The medical device of claim 12, wherein the baseis coupled to the proximal ring by an annular proximal receiver.
 15. Themedical device of claim 14, wherein the base includes one of aprotrusion and a recess, the proximal receiver includes the other of theprotrusion and the recess, and the protrusion is received by the recess.16. The medical device of claim 15, wherein the protrusion and therecess are configured for snap-fit engagement.
 17. The medical device ofclaim 12, wherein a longitudinal axis of the access portion is coaxialwith a longitudinal axis of the wound protector.
 18. A method ofretracting and sealing an incision for laparoscopic procedures,comprising: making an incision in a patient; positioning a woundretractor system proximate the incision, the wound retractor systemincluding: a distal ring, a proximal ring, a sleeve extending betweenthe distal ring and the proximal ring and fixedly coupled to both theproximal ring and the distal ring, and a proximal receiver including arecess; inserting the distal ring through the incision such that thesleeve extends through the incision and the proximal ring is locatedoutside of the incision; retracting the incision with the sleeve;coupling a portion of the proximal ring to the recess of the proximalreceiver so that the receiver restricts movement of the proximal ringand an actual length of the sleeve between the distal ring and theproximal receiver is shortened; and coupling an access device to theproximal receiver.
 19. The method of claim 18, wherein the coupling ofthe access device to the proximal receiver includes a coupling via asnap-fit engagement.
 20. The method of claim 18, wherein retracting theincision includes inverting at least a portion of the sleeve prior tocoupling the portion of the proximal ring to the recess of the proximalreceiver.